BioWorld International Correspondent
LONDON - Apitope Technology Ltd. received £910,000 (US$1.7 million) from the Wellcome Trust to fund a Phase Ib/IIa study of its lead product, a treatment for multiple sclerosis, and announced the appointment of Keith Martin as CEO to take forward the commercial development of the company.
The company is formed around research into autoimmune disease carried out at Bristol University by the scientific founder David Wraith. He is the inventor of Apitopes (Antigen Processing Independent epiTopes) that induce tolerance to abnormal autoimmune responses without affecting the body's immune response to harmful antigens. A U.S. patent on the technology was awarded in January.
The lead product - API-1, 4, 6, 7 - is a soluble, synthetic peptide, which is based on a naturally occurring antigenic protein. Wraith has demonstrated that it can prevent and treat diseases including multiple sclerosis, Type I diabetes and rheumatoid arthritis in animal models. The approach has been validated by other investigators who have shown similar constructs are affective in allergies and rheumatoid arthritis.
API-1, 4, 6, 7 is administered as a nasal spray. It exerts its therapeutic affect via a selective immune re-balancing process, which in preclinical studies was linked to the induction of IL-10-secreting regulatory T cells. The funding from Wellcome will enable the company to carry out the clinical trial in multiple sclerosis, which is expected to complete early in 2007.
Once the safety and efficacy of Apitopes is proved in this trial, the company intends to move onto development programs in other chronic autoimmune diseases. Also, Apitope is working on using the technology to prevent the inactivation of the Factor VIII in hemophilia, in a joint development program with Baxter International Inc.